Paul Baltes, Nebraska Medicine Office of Communications, email@example.com
Bill O'Neill, UNMC Office of Communications, (402) 559-9152, firstname.lastname@example.org
Phil Rooney, Douglas County Health Department, (402) 444-6427, Phillip.Rooney@douglascounty-ne.gov
Khalilah LeGrand, Office of Communications, (402) 471-9313, email@example.com
Lincoln – The Department of Health and Human Services (DHHS) and Douglas County Health Department (DCHD) are aware of an individual who experienced a significant medical event involving thromboembolic occurrence (blood clots) two weeks after receiving the Johnson & Johnson/Janssen Pharmaceuticals COVID-19 vaccine and received treatment at the Nebraska Medicine. The individual is in their late 40s. Any significant medical event that occurs after vaccination is taken very seriously and is thoroughly investigated. DHHS will work closely with DCHD, the patient's medical team, and CDC to ensure any potential connection to vaccination is investigated.
The incident has been entered into VAERS, the Vaccine Adverse Event Reporting System, a national vaccine safety surveillance program run by CDC and the FDA. Anytime a death or any adverse event occurs post-vaccination, the case must be reported into VAERS. This process allows the CDC and FDA to closely monitor and assess any adverse events, for ongoing safety evaluations. As is standard protocol for any significant incident reported in VAERS, it will be fully reviewed. The event occurred in early April and the individual received the vaccine in mid-March.
Some individuals registered for an upcoming vaccination clinic in Douglas County who expected to receive the Johnson & Johnson vaccine were notified that an alternate vaccine would be used due to inventory availability; this is not a result of this incident. However, if they would like to receive the Johnson & Johnson vaccine they will be offered first preference at a clinic next week.
An analysis of phase 3 clinical trial data with approximately 40,000 people showed similar rates of embolic and thrombotic events between those who received the vaccine and those who received a placebo. Among those who received the vaccine, 14 people (.0006 or .06%) developed embolic or thrombotic events. Among those who received a placebo, 10 people (.0005 or .05%) developed embolic or thrombotic events (https://www.fda.gov/media/146338/download, pg. 46). Given the reassuring similarity of events between those who received the vaccine and those who received a placebo, FDA authorized the vaccine for use in the United States.
Over 31,700 Johnson & Johnson vaccinations have been administered in Nebraska and over 4.5 million have been administered nationally to-date. All of the authorized COVID-19 vaccines in the U.S., Pfizer, Moderna and Johnson & Johnson/Janssen had 100% efficacy against COVID-19-related hospitalizations and deaths in phase 3 clinical trials. Vaccinations remain our best defense against COVID-19, our best chance at protecting ourselves and those we love.
Nebraska's Chief Medical Officer Dr. Gary Anthone said, “We are continuing to monitor this and other instances of adverse reactions that occur following vaccination. While we understand that this may raise concerns, we must not forget that vaccinations are our absolute best chance against the spread of virus that has taken the lives of far too many in our state and the country. I cannot stress how important it is for individuals concerned about vaccination to discuss their concerns with their medical provider."
DHHS will share the results of the CDC review once it is finalized.